Innovent announces preliminary results of phase I clinical study of anti-CTLA-4 monoclonal antibody IBI310

Guide: IBI310 is recombinant whole human-derived anticellular T lymphocyte-related antigen 4 (CTLA-4) monoclonal antibody antibody, by increasing the human effect T-cell-mediated anti-tumor immune response and weakening regulatory T-cell-mediated immunosuppressive activity, to inhibit the immune escape of tumor cells, improve the body's own immune response to tumor cells, so as to achieve the purpose of treating a variety of tumorsSuzhou, China, June 3, 2020 , Sinda Biopharma, a biopharmaceutical company dedicated to the development, production and sale of innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, and autoimmune, announced its restructuring in the form of an online announcement at the 56th Annual Meeting of the American Society of Clinical Oncology (ASCO) Preliminary results of human-derived anticellular T lymphocyte-related antigen 4 (CTLA-4) monoclonal antibody (research code: IBI310) Phase I clinical study (NCT03545971 study) (onlinepublication, abstract no302489)the NCT03545971 study presented at ASCO's annual meeting is an open study designed to evaluate the tolerance, safety, and antitumor activity of subjects with advanced malignancies at IBI310 monodrug and its joint Dabersu ® (Cindilly monoantine injection) for the treatment of subjects with advanced malignancies, divided into Ia and Ib phasesAmong them, Ia is IBI310 single drug treatment, indications are advanced solid tumors with failed standard treatment, Ib is the combination of Cindy sepsal therapy, and indications are advanced melanomaKey clinical data include:as of November 12, 2019, the Ia study had a total of 10 subjects in the group, the Ib study had 17 subjects in the group, and no dose-limiting toxicity (DLT) in The Ia and Ib were present, and a dose expansion of the Ia is currently under wayThe most common adverse events associated with the study drug during the ia and Ib periods were itchy, the ia did not appear during treatment of 3 or higher (TEAE), and only 1 case of Phase Ib had A TRAE of 3 or higher (AST elevation) without the occurrence of the teaE leading to death3 subjects in the Phase Ib 3mg combined dose group had at least 1 tumor assessment, of which 1 subject experienced objective remissionProfessor Guo Jun, vice president of the Oncology Hospital of Peking University inand director of the Department of Internal Medicine for Kidney Cancer Melanoma, said: "In recent years, some breakthroughs have been made in the clinical treatment of melanoma, with more treatment models than other malignant tumorsImmunotherapy is one of the most critical breakthroughs in patients with advanced melanoma, with a one-year survival rate from 25% to 35% in the 1990s to 75% todayThe Results of Checkmate-067 show that double immunotherapy is used for first-line treatment of advanced melanoma, which can significantly improve prognosis compared to single-drug immunotherapyThe preliminary results of the NCT03545971 study show that IBI310 has acceptable safety and efficacyWe hope to see more positive data in the next study"CTLA-4 is an important immunosuppressive receptor, and several clinical studies targeting CTLA-4 are under way at home and abroad, and only one antibody drug targeting CTLA-4 is currently on the market," said DrZhou Hui, Vice President, Medical Science and Strategic Oncology, Cinda Biopharmaceutical Group, IBI310 is the fastest-growing anti-CTLA-4 monoclonal antibody in China The clinical results of IBI310 Union Cindy Synantizumab show edimen and anti-tumor activity, showing that combination therapies can play a synergistic and enhanced role Currently, Phase II/III clinical trials of IBI310 United Cindy singifa for multiple tumors are under way, and we hope to evaluate The IBI310 United Cindy Singli singifa efficacy data at an early date to benefit more patients "
on IBI310 (anti-CTLA-4 monoclonal antibody) IBI310 is recombinant whole human-derived anticellular antist-related antigen 4 (CTLA-4) monoclonal antibody resistance, by increasing the body's active T-cell-mediated antitumor immune response and weakening regulatory T-cell-mediated immunosuppression activity, to improve the immune response of tumor cells to enhance the immune response to tumor cells on Cinda biological "starting with the letter, up to line", the development of people can afford high-quality biological drugs, is Cinda biological ideals and goals Founded in 2011, Cinda Bio is dedicated to the development, production and marketing of innovative drugs for the treatment of major diseases such as cancer, metabolic diseases and autoimmune On October 31, 2018, Cinda Biopharmaceuticals was listed on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code: 01801 since its inception, the company has stood out among many biopharmaceutical companies with its innovative results and international operating model Established a product chain of 23 new drug species, covering tumors, metabolic diseases, autoimmune and other disease areas, of which 6 varieties were selected in the national "major new drug creation" special, 17 varieties entered clinical research, 5 varieties entered clinical phase III or critical clinical research, 4 single anti-drug products market applications were accepted by NMPA, 3 of which were included in the priority review, 1 product (Cindy Syngenta, trade name: Daberschu ®, English trademark: TYVYT ®) was approved by NMPA, the first approved indication is recurrent/refractive classic Hodgkin's lymphoma, and in November 2019 became the only PD-1 inhibitor to enter the new national health insurance catalog